Role: Senior NPI Process Development Engineer
Location: Ballybrit, Galway
Reports to: NPI Process Development Engineering Manager (Supply Chain TLCME)
Job Summary:

CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Senior NPI Process Development Engineer located in Galway, Ireland. This is a permanent role.

This position supports the Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson. The CSS Group consists of four diverse businesses including Acclarent, Biosense Webster (BWI), Cerenovus, and Mentor.

In this role, the candidate will be a core member of a cross functional teams responsible for developing and delivering complex acute ischemic stroke projects with significant technical challenges from initial concept through to commercialisation.

The candidates’ primary responsibility will be to work with the product development team, the suppliers of raw materials, and suppliers of manufactured assemblies, from individual components to final packaged, sterilised devices. The role will be involved throughout the entire product and process development cycle from initial prototyping through to process validation and commercialisation.
The key goals will be to ensure that optimal materials, suppliers, and manufacturing processes are selected and developed to deliver a high quality, capable, right- first-time product output at maximum yields and efficiencies to achieve/exceed manufacturing quality and cost targets.

Duties and Responsibilities

• Work collaboratively on cross-functional project teams to develop robust product design to ensure capable manufacturing processes (Design for Manufacture).
• Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently.
• Assess new and existing raw materials, component, and assembly suppliers for technical and manufacturing capabilities.
• Drive process/product improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.
• Manage prototype builds to support characterization and develop assessment strategies.
• Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines.
• Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices.
• Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
• Monitor supplier performance and provide technical support to resolve issues.
• Implement changes under the Cerenovus change management system.
• Other duties as assigned or required.

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Qualifications

Required Experience & Education

• Degree in Mechanical or Biomedical Engineering or equivalent.
• At least 3-5 years of medical device medical process/device design and development experience in a regulated environment.

Desirable Experience

• Prior experience in medical device catheter process design and or manufacturing is highly desirable.
• Understanding of product lifecycle and validation requirements for new product introduction.
• Experienced in developing validation strategies for equipment or processes, including preparation of FMEA’s protocols and reports.
• Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC)
• Project Management experience, developing project schedules and managing resources and execution.
• Experience in managing technical relationships with external suppliers and OEM is preferred.
• Design tools and practices expertise including Design for Manufacture, Lean assembly, Solidworks, Prototyping and Test method development.
• Strong understanding and proven experience using appropriate statistical tools throughout each project lifecycle stage.
• Excellent communication / interpersonal skills required.
• Ability to multi-task, working on multiple projects simultaneously.
• High level of technical writing and reporting skills.
• Strong work ethic, creative problem solving, capable of working on own initiative.

Cerenovus:
CERENOVUS, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

What is it like to work at CERENOVUS Galway?

• Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose.
• We are continuing to better our understanding of clot science, through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and, overall, advance the treatment of acute ischemic stroke.
• Strong new product pipeline and the fastest growing medical device company within J&J.
• From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.

This is what awaits You:
This is an opportunity to work with a ground-breaking biomedical. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education.

Live Our Credo & Pursue Our Purpose:
As part of the Johnson & Johnson family of companies, Our Purpose is ‘We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.’ We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.

Diversity, Equity & Inclusion:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and everyone feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at
Johnson & Johnson means “You Belong”.

Equal Opportunity:
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.